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Discovery escapes clinical trial requirement for Surfaxin

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Discovery Labs no longer has to conduct an additional clinical trial for its respiratory distress syndrome agent Surfaxin (lucinactant), following written guidance recently received from FDA, the firm announced Feb. 16. The agency has determined that all that is needed is additional preclinical work for Surfaxin, which has been through four review periods already, to gain approval to prevent RDS in premature infants. Discovery had previously disclosed an agreement with FDA that an additional, limited clinical trial would be done for final validation of a fetal rabbit biological activity test (a quality control adjustment to address a lingering chemistry, manufacturing and controls issue) (1Pharmaceutical Approvals Monthly, October 2009). However, because an acceptable model of RDS exists - preterm lambs - the model can be used for the BAT validation instead. The new option "presents an opportunity to significantly reduce the time and expense needed to gain approval," and the firm plans to submit a full response in the first quarter of 2011
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